OSMED TISSUE EXPANDER

• K Number: K010852
• Device Name: OSMED TISSUE EXPANDER
• Manufacturer: IOP, INC.
• Date Cleared: 2001-08-13 ( 145 days)
• Product Code: NFM
• Regulation Number: 886.3320
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: K060151

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 886.3320 Eye sphere implant.

(a)
Identification. An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.(b)
Classification. Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.